Product code DZA
- Device name
- Drill, Dental, Intraoral
- Medical specialty
- Dental
- Device class
- 1
- Regulation number
- 872.4130
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K984508 | SURGICAL CONTRA-ANGLE HANDPIECES, MODELS 975 AE,979 E/KM, 985 AE, 986 AE, 988 E/KM AND SURGICAL STRAIGHT HANDPIECES MOD | W&H Dentalwerk Buermoos GmbH | 1999-06-25 |
| K962979 | S-53 INTRORAL DENTAL SYSTEM | Del Medical Systems Corp. | 1996-09-25 |
| K954790 | PROFILE NICKEL TITANIUM ROTARY INSTRUMENTS | Tulsa Dental Products, Ltd. | 1996-01-16 |
| K914724 | ADA SHANK EXTENSION | Implant Corp. of America | 1993-07-27 |
| K905418 | GATES GLIDDEN DRILLS | The Hygenic Corp. | 1991-07-25 |
| K901097 | FILLOCK REAMER | Ivoclar North America, Inc. | 1990-04-25 |
| K896149 | ANEST-EZE DENTAL DRILL RA#2 | Signature One Products, Inc. | 1990-01-19 |
| K884187 | INDENTEC DRILL RA #1 | Phillip C. Crawford, D.D.S. | 1988-12-22 |
| K811113 | RIESS-LUHR | Allomedic | 1981-06-16 |
| K801887 | DRILL, DENTAL | Aesculap Instruments Corp. | 1980-08-20 |
| K801888 | HANDPIECE, DENTAL | Aesculap Instruments Corp. | 1980-08-20 |
| K761275 | AIROTOS LF HANDPIECE | Dentsply Intl. | 1976-12-23 |
| K760956 | SURGICAL MICRO DRILL | American Safety Equipment Corp. | 1976-11-19 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00887919581741 | DENTFLEX FIBER POST | Peter Brasseler Holdings, LLC | 2026-09-25 |
| 00887919581765 | DENTFLEX FIBER POST | Peter Brasseler Holdings, LLC | 2026-09-25 |
| 00887919581727 | DENTFLEX FIBER POST | Peter Brasseler Holdings, LLC | 2026-09-25 |
| 08800394921415 | Neobiotech Implant System | Neobiotech. co., ltd | 2026-09-22 |
| 08800394921477 | Neobiotech Implant System | Neobiotech. co., ltd | 2026-09-22 |
| 08800394921460 | Neobiotech Implant System | Neobiotech. co., ltd | 2026-09-22 |
| 08800394921453 | Neobiotech Implant System | Neobiotech. co., ltd | 2026-09-22 |
| 08800394921446 | Neobiotech Implant System | Neobiotech. co., ltd | 2026-09-22 |
| 08800394921439 | Neobiotech Implant System | Neobiotech. co., ltd | 2026-09-22 |
| 08800394921422 | Neobiotech Implant System | Neobiotech. co., ltd | 2026-09-22 |
| 08800394921408 | Neobiotech Implant System | Neobiotech. co., ltd | 2026-09-22 |
| 08800394921392 | Neobiotech Implant System | Neobiotech. co., ltd | 2026-09-22 |
| 08800394921378 | Neobiotech Implant System | Neobiotech. co., ltd | 2026-09-22 |
| 08800394921293 | Neobiotech Implant System | Neobiotech. co., ltd | 2026-09-22 |
| 08800394921309 | Neobiotech Implant System | Neobiotech. co., ltd | 2026-09-22 |
| 08800394921316 | Neobiotech Implant System | Neobiotech. co., ltd | 2026-09-22 |
| 08800394921323 | Neobiotech Implant System | Neobiotech. co., ltd | 2026-09-22 |
| 08800394921330 | Neobiotech Implant System | Neobiotech. co., ltd | 2026-09-22 |
| 08800394921347 | Neobiotech Implant System | Neobiotech. co., ltd | 2026-09-22 |
| 08800394921354 | Neobiotech Implant System | Neobiotech. co., ltd | 2026-09-22 |
| 08800394921361 | Neobiotech Implant System | Neobiotech. co., ltd | 2026-09-22 |
| 08800394921385 | Neobiotech Implant System | Neobiotech. co., ltd | 2026-09-22 |
| 08059224218007 | INVASIVE ACCESSORIES AND INSTRUMENTS | RHEIN 83 SRL | 2026-08-27 |
| 08059224218014 | INVASIVE ACCESSORIES AND INSTRUMENTS | RHEIN 83 SRL | 2026-08-27 |
| 08059224218038 | INVASIVE ACCESSORIES AND INSTRUMENTS | RHEIN 83 SRL | 2026-08-27 |
| 08059224218250 | INVASIVE ACCESSORIES AND INSTRUMENTS | RHEIN 83 SRL | 2026-08-27 |
| 06942686761223 | Drill | Chengdu Besmile Medical Technology Co., Ltd. | 2026-08-21 |
| 06942686761230 | Drill | Chengdu Besmile Medical Technology Co., Ltd. | 2026-08-21 |
| 06942686761247 | Drill | Chengdu Besmile Medical Technology Co., Ltd. | 2026-08-21 |
| 00887919581772 | DENTFLEX FIBER POST | Peter Brasseler Holdings, LLC | 2022-12-01 |